Systemic Fungal Infections in ICU Patients

September 20, 2017 updated by: Shaimaa Selim, Assiut University

Systemic Fungal Infections in Intensive Care Unit Patients

This study aims to :

  1. Diagnosis of Systemic fungal infections in ICU patients.
  2. Detection the most common fungal species in ICU.
  3. Detection of in vitro antifungal sensitivity pattern

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Systemic fungal infections are a significant and growing public health problem ,Over the past few years, major advances in healthcare have led to an unwelcome increase in the number of life-threatening infections due to true pathogenic and opportunistic fungi ,These have a significant impact on morbidity, mortality, length of hospital stay, and healthcare costs in critically ill patients in intensive care unit ( ICU).

Health care workers encounter at risk patients in ICU in various settings : including diabetes mellitus, renal insufficiency, surgery (especially abdominal surgery), the use of broad-spectrum antibiotics, parenteral nutrition, hemodialysis, mechanical ventilation, the presence of central vascular catheters, and therapy with immunosuppressive agents,Prolonged treatment with corticosteroids before ICU admission, liver cirrhosis with prolonged ICU stay (.7 days), solid organ cancer, HIV infection and lung transplantation are also considered as risk factors ,It can also occur following trauma or invasion of wounds covered with contaminated dressings, e.g. in the ICU. One outbreak of gastric mucormycosis in ICU patients reported in Spain arose in association with the use of contaminated wooden tongue depressors in critically ill patients.

Candida and Aspergillus species are the most frequent causes of healthcare-associated fungal infections in these patients, Although Candida infections are the most frequent fungal infections in ICU patients, invasive aspergillosis is associated with higher morbidity and mortality rates even in the absence of traditional risk factors,Invasive candidiasis is a highly lethal infection associated with mortality rates between 40 and 60 %. The five most common Candida species are Candida albicans, Candida glabrata, Candida tropicalis, Candida parapsilosis, and Candida krusei.

Accurate diagnosis of invasive fungal infection is crucial so that appropriate antifungal agents can be started rapidly. However, early diagnosis is not always easy. Microscopic examination is rapid and can be helpful but a negative result does not exclude infection. Blood cultures are positive in only 50-70 % of cases of Candida BSI, Furthermore, it can take several days before Candida is identified at the species level and antifungal susceptibility data are available but remain the gold stander in diagnosis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This study will include patients who will be admitted to intensive care unit in Assiut University Hospital regardless to age and sex.

Description

Inclusion Criteria:

  • Suppressed immunity such as: (patients with malignancy under chemotherapy, prolonged use of corticosteroids.………etc)
  • Manifestations of chest infection e.g.cough, Haemoptysis, dyspnea and chest discomfort.
  • Persistent fever resistant to antibiotic therapy.
  • Urinary manifestations resistant to antibiotic therapy.

Exclusion Criteria:

  • Patients who received antifungal therapy within 3 days prior to sample collection.
  • Patients refused to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Positive cultures of collected specimens from patients in ICU with suspected SFI.
Time Frame: 2weeks
samples (blood ,urine and sputum) will be taken under complete aseptic precautions in sterile containers and carried immediately for culturing on sabouraud dextrose agar .Positive cultures help in early diagnosis of systemic fungal infections
2weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 28, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SFI in ICU Patients

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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